Cleared Traditional

K091814 - FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESS...

Also marketed or referenced as:
TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE

K091814 is the FDA 510(k) clearance for FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESS... by Taidoc Technology Corporation. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K091814 · Taidoc Technology Corporation · Chemistry device
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Nov 2009
Decision
155d
Days
Class 2
Risk

K091814 is an FDA 510(k) clearance for the FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on November 20, 2009 after a review of 155 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Taidoc Technology Corporation devices

Submission Details

510(k) Number K091814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2009
Decision Date November 20, 2009
Days to Decision 155 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 88d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 190
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